Recall Z-0391-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Completed
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator. Reason: The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted.".
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-11-08
- Firm location
- Mounds View, MN, United States
Product description
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Reason for recall
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Data sourced from openFDA. This site is unofficial and independent of the FDA.